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Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy


Inclusion Criteria:



- Histologically or cytologically confirmed unresectable locally advanced or metastatic
(stage IIIb or IV) Non-small Cell Lung Cancer (NSCLC)

- Recurrent disease (either no response to treatment or subsequent relapse after an
objective response) that has progressed after first-line platinum based therapy

- Male or female ≥ 18 years of age

- Anticipation of more than 3 months survival

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1

- Adequate organ and bone marrow function

Exclusion Criteria:

- Prior Tyrosine Kinase Inhibitor (TKI) therapy

- Anticipation of need for a major surgical procedure or radiation therapy during the
study

- Remaining influence of previous therapies such as radiotherapy, surgery,
immunotherapy within 4 weeks prior to start of study treatment

- Treatment with anticancer medication within 4 weeks before study treatment, currently
enrolled in another investigational drug study, or enrolled in another
investigational drug study within 4 weeks of start of treatment

- History of any of the following events within 6 months prior to start of study
treatment: myocardial infarction, severe/unstable angina pectoris,
coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I
Congestive Heart Failure (CHF), cerebrovascular accident or cerebral infarction,
pulmonary embolism, deep vein thrombosis, or other clinically significant
thromboembolic event; clinically significant pulmonary disease (eg, severe
Chronic-Obstructive Pulmonary Disease (COPD) or asthma)

- Severe edema, ascites fluid, pericardial or pleural effusion or pericardial
involvement with the tumor within 6 months prior to start of study treatment, or
which require steroid therapy/ diuretic therapy

- Subjects with brain metastasis (defined as untreated, symptomatic or requiring
steroids or anticonvulsant medications to control associated symptoms)

- Subjects with clinically significant active infection which requires antibiotic
therapy, or who are hepatitis B surface antigen (HBsAg)-, hepatitis C virus (HCV)- or
human immunodeficiency virus (HIV)-positive or receiving antiretroviral therapy

- Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks),
inflammatory bowel disease, or partial bowel obstruction

- Diabetes mellitus requiring insulin, or a history of poor serum glucose control with
the use of non-insulin diabetes medications

- Treatment with Thiazolidinedione(TZDs) within 4 weeks prior to start of study
treatment

- History of a second malignancy, with the exception of in situ cervical cancer or
adequately treated basal cell or squamous cell carcinoma of the skin

- Poorly-controlled blood pressure as judged by the Investigator

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment Emergent Adverse Events

Outcome Description:

Evaluate the safety and tolerability of CS-7017 in combination with erlotinib Number of subjects reporting Treatment Emergent Adverse Events (TEAEs), as a measure of safety and tolerability.

Outcome Time Frame:

treatment continues until desease progression, unacceptable toxicity or consent withdrawal

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

CS7017-A-A110

NCT ID:

NCT01199068

Start Date:

June 2010

Completion Date:

December 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • PPAR gamma agonist
  • Tumor
  • Cancer
  • Antineoplastic Agent
  • Respiratory Tract Neoplasms
  • Erlotinib
  • Protein Kinase Inhibitors
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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